Bioheng Therapeutics Receives FDA RPDD for Off‑The‑Shelf CAR‑T CTD402
Bioheng Therapeutics (China) announced that the U.S. Food and Drug Administration (FDA) has granted Rare...
Cell-therapy
Suzhou HemaCell Receives NMPA IND Approval for First‑In‑Class Megakaryocyte Injection – Thrombocytopenia Treatment
Suzhou HemaCell Therapeutics, a platelet‑regeneration‑focused cell‑therapy developer, announced that the Center for Drug Evaluation (CDE)...
Chengdu Ucello’s UC101 CAR‑T Gains NMPA Approval
China‑based Chengdu Ucello Biotechnology Co., Ltd. announced that its Investigational New Drug (IND) application for...
Kite Pharma Acquires Interius BioTherapeutics for $350 Million to Boost CAR Therapy Platform
On August 22, 2025, Kite Pharma, Inc., a subsidiary of Gilead Sciences (NASDAQ: GILD), announced...
3D Medicines and CATUG Biotech Forge Strategic Alliance in mRNA-LNP Innovation
China-based 3D Medicines (HKG: 1244) has entered into a strategic cooperation framework agreement with CATUG Biotechnology....
Genentech to End $2B Collaboration With Adaptive Biotechnologies on T-Cell Therapies
Genentech, a member of the Roche Group (SWX: ROG, OTCMKTS: RHHBY), will terminate its strategic...
iRegene Therapeutics’ NouvNeu001 Receives FDA Fast Track Designation for Parkinson’s Therapy
China-based iRegene Therapeutics announced on August 15, 2025, that its self-developed injectable product, NouvNeu001, has...
Qihan Biotech’s QT-019B Gains FDA IND Approval for Autoimmune Diseases
Hangzhou Qihan Biotech Co., Ltd. announced that its self-developed universal dual-target CAR-T cell product, QT-019B,...
Hebei Senlang’s SENL103 CAR-T Therapy Approved for Refractory Generalized Myasthenia Gravis in China
Hebei Senlang Biotechnology Co., Ltd. announced that its SENL103 autologous T-cell infusion has received clinical...
UTC Therapeutics Gains FDA Clearance for CAR-T Therapy UCLM805 in MSLN-Positive Solid Tumors
China-based cell therapy biotech UTC Therapeutics announced receiving clearance from the US Food and Drug...
Porton Advanced and Cellstore Partner to Optimize Cell Therapy Drug Cryopreservation
China-based Contract Development and Manufacturing Organization (CDMO) Porton Advanced Solutions Ltd. and Cellstore announced today...
HRAIN Biotech’s HICARA Approved by NMPA for Relapsed/Refractory LBCL
The National Medical Products Administration (NMPA) officially approved the New Drug Application (NDA) for lenecabtagene...
Cedicine Biotech’s Umbilical Cord Blood Mononuclear Cell Injection Gains CDE Approval for Clinical Trial
China-based Cedicine Biotechnology announced today that the Center for Drug Evaluation (CDE) of the National...
Novatim and ERIGEN Ink Licensing Pact for Dual-Target CAR-T Therapy KQ-2003
Novatim Immune Therapeutics (Zhejiang) Co., Ltd. announced a strategic cooperation with US-based biopharmaceutical company ERIGEN...
IASO Biotherapeutics Receives Orphan Drug Designation in South Korea for Fucaso in Multiple Myeloma
China-based IASO Biotherapeutics announced that its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso...
SCG Cell Therapy Obtains NMPA Approval for SCG101V in Chronic HBV Study
China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) has approved SCG...
3SBio Partners with Thermo Fisher to Advance Cell and Gene Therapy Solutions
China-based 3SBio Inc. (HKG: 1530) announced last week a strategic partnership with US-based life sciences...
AbbVie to Acquire Capstan Therapeutics for Its First-in-Class CAR-T Candidate
US-based pharmaceutical giant AbbVie (NYSE: ABBV) is poised to acquire fellow American firm Capstan Therapeutics,...
BMS Secures FDA Approval for Updated Labels of Breyanzi and Abecma
US major Bristol-Myers Squibb (BMS; NYSE: BMY) announced that the US Food and Drug Administration...
FDA Removes REMS Requirements for BCMA- and CD19-Targeted CAR-T Therapies
The U.S. Food and Drug Administration (FDA) last week announced the removal of Risk Evaluation...